FDA ta Amince da Gwajin IDE na HistoSonics don Sauti na Farko

HistoSonics na Minneapolis sun haɓaka tsarin su na Edison don kai hari da kashe ciwan koda na farko da aka yi niyya.Yana yin sa ba tare da ɓata lokaci ba, ba tare da yanka ko allura ba.Edison yayi amfani da sabon maganin sauti mai suna histology.
HistoSonics yana samun goyon bayan wasu manyan ƴan wasa a masana'antar fasahar likitanci.A cikin Mayu 2022, kamfanin ya shiga yarjejeniya tare da GE HealthCare don amfani da fasahar hoto ta duban dan tayi don samar da sabon nau'in maganin katako na sauti.A cikin Disamba 2022, HistoSonics ya tara dala miliyan 85 a zagaye na tallafi wanda Johnson & Johnson Innovation ke jagoranta.
Kamfanin ya ce amincewar FDA na binciken Hope4Kidney ya dogara ne akan sabon binciken daga binciken Hope4Liver.Dukansu gwaje-gwajen sun sami nasarar amincinsu na farko da ingantaccen sakamako a cikin niyya ta ciwace-ciwacen hanta.
"Wannan amincewa wani muhimmin mataki ne ga kamfaninmu yayin da muke ci gaba da fadada aikace-aikacen fasaha na slicing nama da kuma amfani da ita ga maganin cututtuka da ke shafar rayuwar mutane da yawa," in ji Mike Blue, Shugaba da Shugaba na HistoSonics.Mun yi farin cikin fadada kwarewarmu.nasara mai niyya da jiyya a cikin hanta ta amfani da ingantaccen dandalin Edison namu, wanda ya haɗu da ci gaba na hoto da damar yin niyya tare da sa ido kan jiyya na lokaci-lokaci.
Magani na yanzu don ciwace-ciwacen koda sun haɗa da ɓangaren nephrectomy da kuma zubar da zafi, in ji HistoSoncis.Wadannan hanyoyi masu cin zarafi suna nuna zub da jini da rikice-rikice masu kamuwa da cuta waɗanda za a iya kaucewa tare da biopsy na nama mara lalacewa, in ji kamfanin.
Wannan maganin na iya lalata nama da aka yi niyya ba tare da lalata naman koda mara niyya ba.Tsarin lalata ƙwayoyin sel a cikin sassan nama na iya kiyaye aikin tsarin urinary na kodan.
Tarihi Hario Hoto ya jagorance sauti mai kyau yana amfani da mai ɗaukar hoto da fasaha mai amfani da shi.The far yana amfani da mayar da hankali acoustic makamashi don haifar da sarrafawa acoustic cavitation to mechanically rushe da kuma liquefy manufa hanta nama a subcellular matakin.
Kamfanin ya kuma ce, dandalin na iya samar da saurin murmurewa da karbewa, da kuma iya sa ido, in ji kamfanin.
Edison ba a kasuwa a halin yanzu, yana jiran bitar FDA don alamun hanta.Kamfanin na fatan cewa gwaje-gwaje masu zuwa za su taimaka fadada alamun ƙwayar koda.
"Aikace-aikacen ma'ana na gaba shine koda, saboda maganin koda yana kama da maganin hanta dangane da tsarin aiki da tsarin jiki, kuma Edison an tsara shi musamman don kula da kowane bangare na ciki a matsayin farawa," in ji Blue."Bugu da ƙari, yaduwar cutar koda ya kasance mai girma, kuma yawancin marasa lafiya suna cikin sa ido ko jira."
An yi fayil ɗin ƙarƙashin: Gwaje-gwaje na asibiti, Gudanar da Abinci da Magunguna (FDA), Hoto, Oncology, Yarda da Ka'ida / Tag Yarda da: HistoSonics Inc.
Sean Wooley is an Associate Editor writing for MassDevice, Medical Design & Outsourcing and Business News for drug delivery. He holds a bachelor’s degree in multiplatform journalism from the University of Maryland at College Park. You can reach him via LinkedIn or email shooley@wtwhmedia.com.
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Lokacin aikawa: Fabrairu-14-2023